Microbial Contamination Control Specialist (with Project Management capability)

Job title: Microbial Contamination Control Specialist (with Project Management capability)

Company: Independent Solutions


Job description: Microbial Contamination Control Specialist (with Project Management capability)Location:
Pharmaceutical Manufacturing Facilities (site-based) Kildare
Rate:
TBDRole Summary:The Microbial Contamination Control Specialist is responsible for coordinating and participating in structured assessments of manufacturing areas and equipment to identify critical control points and assess microbial contamination risks. The role requires cross-functional engagement, working closely with engineering, technical services, and quality teams.Key Responsibilities:

• Perform structured microbial contamination assessments across various manufacturing areas and equipment.
• Identify and document critical control points and current controls in place.
• Recommend improvements or corrective actions as required where contamination risks are identified.
• Coordinate and manage assessment activities, ensuring adherence to the established framework and timelines.
• Engage cross-functional teams (engineering, technical services) during the assessment process.
• Prepare clear documentation and reports detailing findings, risks, and recommendations.
• Provide guidance on microbial risk mitigation strategies.

Required Qualifications:

• Degree in Microbiology, Biotechnology, Pharmaceutical Sciences, or a related field.
• Practical experience in contamination control in a regulated manufacturing environment (e.g., GMP, ISO).
• Knowledge of manufacturing processes and environmental controls.
• Strong project coordination or project management skills.
• Effective communication and stakeholder engagement abilities.

Preferred Qualifications:

• Prior experience conducting microbial or contamination control / risk assessments.

Working Conditions:

• Regular site visits and physical walkdowns for assessment of manufacturing areas and equipment.
• Collaborative environment with engineering, technical services, and quality teams.

Performance Profile: Microbial Contamination Control Specialist

• Successfully complete microbial contamination control assessments across all assigned manufacturing areas.
• Produce comprehensive risk assessments and gap analyses, highlighting critical control points.
• Ensure at least 90% of identified contamination risks are accompanied by actionable, practical recommendations.
• Establish effective working relationships with site engineering and technical service teams to streamline assessment processes.
• Deliver clear, concise reports that meet regulatory and internal quality standards.

Key Measures of Success:

• Timely completion of assessments within agreed timelines.
• Quality and usability of risk assessment outputs.
• Feedback from cross-functional stakeholders (engineering, technical services, QA).
• Proactive identification and resolution of potential contamination risks.

Key Behaviors and Competencies:

• Attention to detail and strong observational skills.
• Ability to manage structured frameworks and maintain process discipline.
• Collaborative, respectful, and clear communication style.
• Critical thinking with a solutions-focused mindset.
• Professional resilience when dealing with complex or ambiguous situations.

Expected salary:

Location: Limerick

Job date: Thu, 08 May 2025 00:43:13 GMT

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